Validated reversed-phase high-performance liquid chromatographic and high-performance thin-layer chromatographic methods for simultaneous analysis of tamsulosin hydrochloride and dutasteride in pharmaceutical dosage forms

A rapid, highly sensitive high performance liquid chromatographic method has been developed for the determination of finasteride(FNS) in bulk drug and in tablets. FNS was eluted from a ODS C18reversed phase column at laboratory temperature (30 ± 2°C) with a mobile phase consisting of methanol and water (80+20) at a flow rate of 1 mL min-1with UV detection at 225 nm. The retention time was ∼ 6.1 min and each analysis took not more than 10 min. Quantitation was achieved by measurement of peak area without using any internal standard. Calibration graph was linear from 2.0 to 30 μg mL-1with limits of detection (LOD) and quantification (LOQ) being 0.2 and 0.6 μg mL-1, respectively. The method was validated according to the current ICH guidelines. Within-day co efficients of variation (CV) ranged from 0.31 to 0.69% and between-day CV were in the range 1.2-3.2%. Recovery of FNS from the pharmaceutical dosage forms ranged from 97.89 – 102.9 with CV of 1.41-4.13%. The developed method was compared with the official method for FNS determination in its tablet forms.

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DEVELOPMENT OF VALIDATED RP-HPLC METHOD FOR THE QUANTITATIVE ANALYSIS OF CHROMIUM PICOLINATE III IN A DIET VINEGAR FORMULATION

INDIAN DRUGS ◽

10.53879/id.50.05.p0048 ◽

2013 ◽

Vol 50 (05) ◽

pp. 48-52

Author(s):

A Lodhi ◽

◽

A Jain ◽

B. Biswal

Keyword(s):

High Performance ◽

Limit Of Detection ◽

High Performance Liquid Chromatographic ◽

Reversed Phase ◽

Hplc Method ◽

Chromium Picolinate ◽

Limit Of Quantification ◽

Pharmaceutical Dosage Forms ◽

Liquid Chromatographic Method ◽

Liquid Chromatographic

A validated high performance liquid chromatographic method was developed for the determination of chromium picolinate in pharmaceutical dosage forms. The analysis was performed at room temperature using a reversed-phase ODS, 5µm (250×4.6) mm column. The mobile phase consisted of acetonitrile: buffer (60:40 V/V) at a flow rate of 0.5 mL/min. The PDA-detector was set at 264 nm. The developed method showed a good linear relationship in the concentration range from 1.5 – 12.5 µg/mL with a correlation coefficient from 0.999. The limit of detection and limit of quantification were 0.0540513 and 0.1637919 µg/mL respectively.

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Thin-layer and high performance liquid chromatographic methods for the analysis of aflatoxins in animal tissues and fluids

Diagnosis of Mycotoxicoses ◽

10.1007/978-94-009-4235-6_22 ◽

1986 ◽

pp. 257-269 ◽

Cited By ~ 3

Author(s):

Robert D. Stubblefield

Keyword(s):

Thin Layer ◽

High Performance ◽

High Performance Liquid Chromatographic ◽

Animal Tissues ◽

Chromatographic Methods ◽

Liquid Chromatographic

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Stability Indicating HPLC-ECD Method for the Analysis of Clarithromycin in Pharmaceutical Dosage Forms: Method Scaling versus Re-Validation

Scientia Pharmaceutica ◽

10.3390/scipharm87040031 ◽

2019 ◽

Vol 87 (4) ◽

pp. 31 ◽

Cited By ~ 2

Author(s):

Makoni ◽

Chikukwa ◽

Khamanga ◽

Walker

Keyword(s):

High Performance ◽

The United States ◽

High Performance Liquid Chromatographic ◽

Dosage Forms ◽

Pharmaceutical Dosage Forms ◽

Analytical Column ◽

Ich Guidelines ◽

Relative Standard ◽

Run Time ◽

Liquid Chromatographic

An isocratic high-performance liquid chromatographic method using electrochemical detection (HPLC-ECD) for the quantitation of clarithromycin (CLA) was developed using Response Surface Methodology (RSM) based on a Central Composite Design (CCD). The method was validated using International Conference on Harmonization (ICH) guidelines with an analytical run time of 20 min. Method re-validation following a change in analytical column was successful in reducing the analytical run time to 13 min, decreasing solvent consumption thus facilitating environmental and financial sustainability. The applicability of using the United States Pharmacopeia (USP) method scaling approach in place of method re-validation using a column with a different L–designation to the original analytical column, was investigated. The scaled method met all USP system suitability requirements for resolution, tailing factor and % relative standard deviation (RSD). The re-validated and scaled method was successfully used to resolve CLA from manufacturing excipients in commercially available dosage forms. Although USP method scaling is only permitted for columns within the same L-designation, these data suggest that it may also be applicable to columns of different designation.

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